Adverse events will be assessed according to the Council for International Organizations of Medical Sciences (CIOMS) I Working Group the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.

Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

Experimental: HAART+ Bevacizumab injection

Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Patients received 3 intralesional injections of bevacizumab (Avastin, Genentech, San Francisco, California) in the target lesion every 2 weeks. Bevacizumab was injected using an insulin syringe in a submucosal plane. The volume injected was based on the size of the target lesion; the dose was 0.2 mL (5 mg) per cm2.

Drug: Bevacizumab

Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3

Other Name: Avastin

Detailed Description:

Once disseminated disease is excluded, histologically confirmed HIV-positive patients with localized Kaposi's sarcoma of the airway will be randomized to receive HAART only or HAART + intralesional bevacizumab.

The primary outcome will be the size of lesions according to RECIST criteria. Patients in the HAART + bevacizumab arm will undergo series of 3 bevacizumab injections of 5 mg/cm3. Follow-up will be carried out through scheduled meetings for office setting examination every week for the first 8 weeks, then every 15 days for two months and finally every month for eight months.

Size of the lesions will be assessed by an independent observer and adverse events will be recorded.

Eligibility

Ages Eligible for Study:

18 Years to 60 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV infected

KS of the oral cavity, pharynx and larynx, histopathologically confirmed

HIV treatment-naïve

Exclusion Criteria:

Airway obstructive lesions

Actively bleeding lesions

Tumor-associated oedema or ulceration

Gastrointestinal KS

KS in other nonnodal viscera

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296815